Blowing the Whistle on Fen-Phen: An Exploration of MeritCare's Reporting of Linkages between Fen-Phen and Valvular Heart Disease

Article excerpt

This study of the process resulting in the Food and Drug Administration's ban of the diet drug fen-phen following the whistle-blowing of MeritCare, a regional health system in Forgo, North Dakota, expands the concept of whistle-blowing to include external stakeholders who publicly expose problems or errors. The investigation evaluates the conditions surrounding the health system's decision to make public the technician's findings; its whistle-blowing procedures, retaliation fears, perceived need for enhanced credibility, and commitment to an ethic of significant choice are chronicled. The authors conclude that external stakeholders may enact many of the processes found in employee whistle-blowing and that consumer protection appears to be an important value in controversial whistle-blowing decisions. The authors also suggest that traditional notions of whistle-blowing are too narrow.

Organizations often face information that exposes problems or wrongdoing or represents dissent. Messages signaling problems or wrongdoing frequently come from internal sources such as employees or from related agencies and organizations aware of problems or wrongdoing. When the organization refuses to take appropriate action in response to these messages, insiders or outsiders may call broader attention to the issue by blowing the whistle. The communicative process of blowing the whistle is critical for organizations and societies seeking to monitor areas of emerging risk that are threatening to an organization's established routines and assumptions (Jensen, 1987; Miceli & Near, 1992; Redding, 1985; Seeger 1997).

The objective of the analysis presented in this article is to examine the public disclosure of serious side effects associated with the combined use of fenfluramine and phentermine, also known as fen-phen, a prescription weight loss drug cocktail produced and actively promoted by Robins Pharmaceuticals and Wyeth-Ayerst, both divisions of American Home Products. In the 1990s, fen-phen was widely prescribed, with as many as 18 million prescriptions written in 1996 alone (Pitts, Crosby, Laufenberg, Meidinger, & Monson, 1998). Although the two drugs had never been approved by the Food and Drug Administration (FDA) for combined use, individual physicians exercising their prerogative to prescribe both drugs in tandem, with the encouragement of American Home Products, made fen-phen one of the pharmaceutical industry's best-selling products (Pitts et al., 1998). These physicians saw fen-phen as an effective prescription for treating obesity. However, in the winter of 1997 an echocardiography technician working for MeritCare Health System (MeritCare) in Fargo, North Dakota, discovered what appeared to be a relationship of fen-phen usage to valvular heart disease. MeritCare staff, expressing serious concern on one hand and serious reservations about the implications of making such an accusation on the other hand, based their decisions on the opinions of several medical, legal, and communication staff members. This group of individuals is noted in this study as the Issues Management Team. Concerned about its ability to draw sufficient attention to the medical risks of taking fen-phen, MeritCare turned for assistance to the world famous Mayo Clinic (Mayo), in Rochester, Minnesota. This collaboration resulted in an article published in the New England Journal of Medicine and a public warning about the dangers of fen-phen usage. In September 1997, the FDA requested that American Home Products withdraw fen-phen from the market (see Table 1).

We focus our analysis on MeritCare's warning about the danger of fen-phen usage as a form of whistle-blowing. Although the whistle-blowers in this case were not employees of the company producing this dangerous product, we argue that this case represents a kind of external or outsider whistle-blowing that reaches beyond the traditional internal form. …